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Op-ed Placement

Lives Hang in the Balance While the FDA Bureaucracy Churns

The McLinn family of Indianapolis is still fighting for their seven-year-old son, Jordan, who was diagnosed at the age of 3 with Duchenne muscular dystrophy. This is an aggressive disease that results in muscle weakness and loss first attacking the extremities, eventually moving to the heart and other internal organs. There is no known cure, yet, but there are treatments that can help manage symptoms and slow progression of the disease.

For people like Jordan McLinn, failure or needless delay of the Food and Drug Administration to grant a compassionate use request (also known as expanded access) can mean the difference between walking or being wheelchair-bound.

Time and time again, the federal government has encroached into a sector of the economy and imposed a one-size-fits-all regulation that stifles competition, hurts small businesses, and creates troubling criminal penalties for lack of compliance. This is epitomized in federal involvement in menu labeling -- regulations and requirements for private businesses to disclose caloric information on physical menus.

FreedomWorks’ is proud to name the Right to Try Act, H.R. 878, as the Bill of the Month for September, 2017. This is companion legislation to the Trickett Wendler Right to Try Act, which passed the Senate last month by unanimous consent. H.R. 878 is sponsored by House Freedom Caucus member, Rep. Andy Biggs (R-Ariz.).

On May 5, 2017, Gov. Jay Inslee (D-Wash.) signed SB 5035, making Washington the 35th Right to Try state. The Right to Try law allows drugs that have passed the initial phase of FDA testing to be tried by various individuals despite the fact the drug has not yet gone through the lengthy process of full approval by the agency.

In his first address to Congress last month, President Trump criticized the Food and Drug Administration’s “slow and burdensome” drug approval process for preventing “too many advances…from reaching those in need.” Indeed, the FDA has repeatedly proven to be a bureaucratic quagmire that slows the development of effective, affordable medication and helps to inflate the price of some drugs to absurd levels.